##### Table of Contents

---

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549



---



FORM 10-QSB/A

(Amendment No. 1)



---



Quarterly Report Under Section 13 or 15(d)

of the Securities Exchange Act of 1934



For the quarterly period ended June 30, 2004



Commission file number 0-15070



---



REGENERX
BIOPHARMACEUTICALS, INC.

(Exact name of small business issuer as specified in its charter)



---



|                         |  |                           
|------------------------ |  | --------------------------
|Delaware                 |  | 52-1253406                
|(State of Incorporation) |  | (IRS Employer I.D. Number)



3 Bethesda Metro
Center

Suite 700

Bethesda, Maryland 20814

(Address of principal executive offices)



Issuers telephone number, including area code: (301) 961-1992



---



Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No ̈



32,628,998 shares of RegeneRx Biopharmaceuticals, Inc. Common Stock, par value $.001 per share, were outstanding as of June 30, 2004.



Transitional Small Business Disclosure Format (Check
One)    Yes ̈No  x



---



---

##### Table of Contents

RegeneRx Biopharmaceuticals, Inc.

Form 10-QSB

Quarterly Period Ended June 30, 2004



INDEX



|           |  |                       |  |                                                                                                                            |  |         
|---------- |  | --------------------- |  | -------------------------------------------------------------------------------------------------------------------------- |  | --------
|           |  |                       |  |                                                                                                                            |  | Page No.
|Part I.    |  | Financial Information
|           |  |                       | 
|           |  | Item 1.               |  | Financial Statements                                                                                                       |  |         
|           |  |                       | 
|           |  |                       |  | Balance Sheets at June 30, 2004 (unaudited) and December 31, 2003                                                          |  | 3       
|           |  |                       | 
|           |  |                       |  | Statements of Operations for the three-months and six-months ended June 30, 2004 (unaudited) and June 30, 2003 (unaudited) |  | 4       
|           |  |                       | 
|           |  |                       |  | Statements of Cash Flows for the six-months ended June 30, 2004 (unaudited) and June 30, 2003 (unaudited)                  |  | 5       
|           |  |                       | 
|           |  |                       |  | Notes to Financial Statements (unaudited)                                                                                  |  | 6       
|           |  |                       | 
|           |  | Item 2.               |  | Managements Discussion and Analysis or Plan of Operation                                                                  |  | 7-8     
|           |  |                       | 
|           |  | Item 3.               |  | Controls and Procedures                                                                                                    |  | 8       
|           | 
|Part II.   |  | Other Information    
|           |  |                       | 
|           |  | Item 1.               |  | Legal Proceedings                                                                                                          |  | 9       
|           |  |                       | 
|           |  | Item 2.               |  | Changes in Securities                                                                                                      |  | 9       
|           |  |                       | 
|           |  | Item 3.               |  | Defaults Upon Senior Securities                                                                                            |  | 9       
|           |  |                       | 
|           |  | Item 4.               |  | Submission of Matters to a Vote of Security Holders                                                                        |  | 9       
|           |  |                       | 
|           |  | Item 5.               |  | Other Information                                                                                                          |  | 9       
|           |  |                       | 
|           |  | Item 6.               |  | Exhibits and Reports on Form 8-K                                                                                           |  | 10-11   
|           | 
|Signatures |  | 12                   



2



---

##### Table of Contents

PART I  FINANCIAL INFORMATION



Item 1. Financial Statements



RegeneRx Biopharmaceuticals, Inc.

Balance Sheets



|                                                                                                                                       |  |               |             |   |                   |   |             |  
|-------------------------------------------------------------------------------------------------------------------------------------- |  | ------------- | ----------- | - | ----------------- | - | ----------- | -
|                                                                                                                                       |  | June 30, 2004 |             |   | December 31, 2003 |  
|                                                                                                                                       |  | (unaudited)   |             |   |                   |  
|ASSETS                                                                                                                                 |  |               |             |   |                   |   |             |  
|Current assets                                                                                                                         |  |               |             |   |                   |   |             |  
|Cash and cash equivalents                                                                                                              |  | $             | 1,612,875   |   |                   | $ | 1,019,889   |  
|Due from related party                                                                                                                 |  |               | 20,074      |   |                   |   | 26,897      |  
|Other current assets                                                                                                                   |  |               | 47,393      |   |                   |   | 36,428      |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Total current assets                                                                                                                   |  |               | 1,680,342   |   |                   |   | 1,083,214   |  
|Fixed assets, net                                                                                                                      |  |               | 3,758       |   |                   |   | 3,377       |  
|Other assets, net                                                                                                                      |  |               | 142,157     |   |                   |   | 23,227      |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Total assets                                                                                                                           |  | $             | 1,826,257   |   |                   | $ | 1,109,818   |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|LIABILITIES AND STOCKHOLDERS EQUITY                                                                                                   |  |               |             |   |                   |   |             |  
|Current liabilities                                                                                                                    |  |               |             |   |                   |   |             |  
|Accounts payable                                                                                                                       |  | $             | 77,716      |   |                   | $ | 81,268      |  
|Accrued expenses                                                                                                                       |  |               | 45,626      |   |                   |   | 91,734      |  
|Letter agreements with vendors                                                                                                         |  |               | 20,046      |   |                   |   | 20,046      |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Total current liabilities                                                                                                              |  |               | 143,388     |   |                   |   | 193,048     |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Commitments                                                                                                                            |  |               |            |   |                   |   |            |  
|Stockholders equity                                                                                                                   |  |               |             |   |                   |   |             |  
|Preferred stock, $.001 par value per share, 1,000,000 authorized; no shares issued                                                     |  |               |            |   |                   |   |            |  
|Common stock, $.001 par value per share, 100,000,000 shares authorized; 32,628,998 and 30,098,968 issued and outstanding,
respectively |  |               | 32,629      |   |                   |   | 30,099      |  
|Additional paid-in capital                                                                                                             |  |               | 42,350,334  |   |                   |   | 40,065,861  |  
|Accumulated deficit                                                                                                                    |  |               | (40,700,094 | ) |                   |   | (39,179,190 | )
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Total stockholders equity                                                                                                             |  |               | 1,682,869   |   |                   |   | 916,770     |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  
|Total liabilities and stockholders equity                                                                                             |  | $             | 1,826,257   |   |                   | $ | 1,109,818   |  
|                                                                                                                                       |  |               |             |   |                   |   |             |  



The accompanying notes
are an integral part of these financial statements.



3



---

##### Table of Contents

RegeneRx Biopharmaceuticals, Inc.

Statements of Operations

(Unaudited)



|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|---------------------------------------------------- |  | --------------------------- | ---------- | - | ------------------------- | - | ---------- | ---- |  | - | ---------- | - |  | - | ---------- | -
|                                                     |  | Three-months ended June 30, |            |   | Six-months ended June 30, |  
|                                                     |  | 2004                        |            |   | 2003                      |   |            | 2004 |  |   | 2003       |  
|Revenues                                             |  | $                           |           |   |                           | $ |           |      |  | $ |           |   |  | $ |           |  
|Expenses                                             |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Research and development                             |  |                             | 144,607    |   |                           |   | 215,541    |      |  |   | 975,947    |   |  |   | 366,380    |  
|General and administrative                           |  |                             | 219,800    |   |                           |   | 216,189    |      |  |   | 551,366    |   |  |   | 355,119    |  
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Total expenses                                       |  |                             | 364,407    |   |                           |   | 431,730    |      |  |   | 1,527,313  |   |  |   | 721,499    |  
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Operating loss                                       |  |                             | (364,407   | ) |                           |   | (431,730   | )    |  |   | (1,527,313 | ) |  |   | (721,499   | )
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Other income (expense)                               |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Other income                                         |  |                             |           |   |                           |   |           |      |  |   |           |   |  |   |           |  
|Interest income                                      |  |                             | 2,821      |   |                           |   | 612        |      |  |   | 6,445      |   |  |   | 2,572      |  
|Other expense                                        |  |                             | (6         | ) |                           |   | (42,949    | )    |  |   | (36        | ) |  |   | (42,949    | )
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Total other income                                   |  |                             | 2,815      |   |                           |   | (42,337    | )    |  |   | 6,409      |   |  |   | (40,377    | )
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Net loss                                             |  | $                           | (361,592   | ) |                           | $ | (474,067   | )    |  | $ | (1,520,904 | ) |  | $ | (761,876   | )
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Basic and diluted net loss per common share          |  | $                           | (0.01      | ) |                           | $ | (0.02      | )    |  | $ | (0.05      | ) |  | $ | (0.03      | )
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  
|Weighted average number of common shares outstanding |  |                             | 32,591,635 |   |                           |   | 27,166,384 |      |  |   | 32,263,881 |   |  |   | 26,953,833 |  
|                                                     |  |                             |            |   |                           |   |            |      |  |   |            |   |  |   |            |  



The accompanying notes
are an integral part of these financial statements.



4



---

##### Table of Contents

RegeneRx Biopharmaceuticals, Inc.

Statements of Cash Flows

(Unaudited)



|                                                                            |  |                           |            |   |      |   |           |  
|--------------------------------------------------------------------------- |  | ------------------------- | ---------- | - | ---- | - | --------- | -
|                                                                            |  | Six-months ended June 30, |           
|                                                                            |  | 2004                      |            |   | 2003 |  
|Cash flows from operating activities:                                       |  |                           |            |   |      |   |           |  
|Net loss                                                                    |  | $                         | (1,520,904 | ) |      | $ | (761,876  | )
|Adjustments to reconcile net loss to net cash used in operating activities: |  |                           |            |   |      |   |           |  
|Depreciation and amortization                                               |  |                           | 2,110      |   |      |   | 1,895     |  
|Compensation expense for stock options                                      |  |                           | 13,621     |   |      |   | 40,649    |  
|Changes in operating assets and liabilities:                                |  |                           |            |   |      |   |           |  
|(Increase) decrease:                                                        |  |                           |            |   |      |   |           |  
|Other current assets                                                        |  |                           | (10,965    | ) |      |   | (21,424   | )
|Due from related party                                                      |  |                           | 6,823      |   |      |   | 3,904     |  
|Increase (decrease):                                                        |  |                           |            |   |      |   |           |  
|Accounts payable                                                            |  |                           | (3,552     | ) |      |   | 18,902    |  
|Accrued expenses                                                            |  |                           | (46,108    | ) |      |   | (12,479   | )
|                                                                            |  |                           |            |   |      |   |           |  
|Net cash used in operating activities                                       |  |                           | (1,558,975 | ) |      |   | (730,429  | )
|                                                                            |  |                           |            |   |      |   |           |  
|Cash flows from investing activities:                                       |  |                           |            |   |      |   |           |  
|Purchase of fixed assets                                                    |  |                           | (1,598     | ) |      |   |          |  
|Patents costs                                                               |  |                           | (119,823   | ) |      |   |          |  
|                                                                            |  |                           |            |   |      |   |           |  
|Net cash used in investing activities                                       |  |                           | (121,421   | ) |      |   |          |  
|                                                                            |  |                           |            |   |      |   |           |  
|Cash flows from financing activities:                                       |  |                           |            |   |      |   |           |  
|Issuance of common stock                                                    |  |                           | 2,259,737  |   |      |   | 2,000,000 |  
|Proceeds from exercise of warrants                                          |  |                           | 13,645     |   |      |   | 10,000    |  
|Proceeds from exercise of options                                           |  |                           |           |   |      |   | 1,650     |  
|Repayments of Subscriptions Receivable                                      |  |                           |           |   |      |   | 190,000   |  
|Stock Offering Costs                                                        |  |                           |           |   |      |   | (10,000   | )
|                                                                            |  |                           |            |   |      |   |           |  
|Net cash provided by financing activities                                   |  |                           | 2,273,382  |   |      |   | 2,191,650 |  
|                                                                            |  |                           |            |   |      |   |           |  
|Net increase in cash and cash equivalents                                   |  |                           | 592,986    |   |      |   | 1,461,221 |  
|Cash and cash equivalents at beginning of period                            |  |                           | 1,019,889  |   |      |   | 474,338   |  
|                                                                            |  |                           |            |   |      |   |           |  
|Cash and cash equivalents at end of period                                  |  | $                         | 1,612,875  |   |      | $ | 1,935,559 |  
|                                                                            |  |                           |            |   |      |   |           |  
|Disclosure of non-cash transactions:                                        |  |                           |            |   |      |   |           |  
|Surrender of common stock for repayment of subscriptions receivable         |  | $                         |           |   |      | $ | 110,000   |  
|                                                                            |  |                           |            |   |      |   |           |  



The accompanying notes
are an integral part of these financial statements.



5



---

##### Table of Contents

RegeneRx Biopharmaceuticals, Inc.

Notes to Financial Statements

For the three-months ended June 30, 2004 and 2003 (Unaudited)



A. GENERAL



RegeneRx Biopharmaceuticals, Inc. (the Company), a Delaware corporation, was incorporated in 1982. The Company operates predominately in a single industry
segment, the biotechnology industry. In general, the biotechnology industry consists of researching and developing new pharmaceutical products for the treatment of diseases or conditions that arise as a result of infections, cancer, autoimmune
disease and genetic abnormalities. The Companys current primary business focus is the commercialization of Thymosin beta 4, a 43 amino acid peptide. The Company is concentrating its efforts on the use of Thymosin beta 4 for the treatment of
injured tissue and non-healing wounds to enable more rapid repair and/or tissue regeneration.



The Company currently has no products that have received regulatory approval. During 1997, the Company entered into a Material Transfer AgreementCooperative Research and Development Agreement (CRADA)
with the National Institutes of Health (NIH). In exchange for providing Thymosin beta 4 and certain data, the Company received an option to elect to negotiate for an exclusive or non-exclusive commercialization license from the NIH
pursuant to a patent application filed by NIH in 1998. On February 6, 2001, the Company signed a licensing agreement with NIH whereby the Company obtained an exclusive world-wide license to Thymosin beta 4 under the patent application filed in 1998.
In exchange for the exclusive license, the Company must make certain royalty and milestone payments to the NIH. To date, all payments due have been made.



B. FINANCIAL STATEMENTS



The Balance Sheet as of June 30, 2004, the Statements of Operations for the three-month periods ended June 30, 2004 and June 30, 2003, and the Statements of Cash Flows
for the six-month periods ended June 30, 2004 and June 30, 2003, have been prepared without audit. In the opinion of management, all adjustments necessary to present fairly the financial position, results of operations, and cash flows at June 30,
2004, and for the periods then ended, have been recorded. All adjustments recorded were of a normal recurring nature.



The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and
pursuant to rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial
statement presentation. In the opinion of management, such unaudited interim information reflects all necessary adjustments, consisting of only normal recurring adjustments, necessary to present the Companys financial position and results of
operations for the periods presented. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full fiscal year. These statements should be read in conjunction with the financial statements and
related notes included in the Companys Form 10-KSB for the year ended December 31, 2003.



The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenue and expenses during the reported period. Actual results could differ from those estimates.



C. NET LOSS PER
SHARE



Net loss per share is based on the
weighted average number of common shares outstanding during the three-month periods ended June 30, 2004 and June 30, 2003. During these periods options and warrants were not included in the calculation as their effect would be antidilutive.



6



---

##### Table of Contents

ITEM 2. Managements Discussion and Analysis or Plan of Operation



This item should be read in conjunction with the unaudited financial statements and notes thereto of the Company contained in Item 1 of this report.



Plan of Operation



Since its inception in 1982, the Companys activities had consisted of conducting research and development, sponsoring clinical trials of its proprietary products,
the construction and equipping of laboratory and production facilities, and the manufacture of products for research, testing and clinical trials. In 2000, the Company adopted a modified business plan calling on the outsourcing of most of the
activities necessary to its mission of developing its Thymosin beta 4 (Tb4) technology for the treatment of chronic wounds. This business
model allows for the rapid and effective deployment of necessary resources without the burden of expensive and unwieldy infrastructure. It also allows the company to expand or contract its efforts depending on capital resources or other
circumstances. The Company has not generated revenues from operations and does not anticipate generating product revenues or other revenues from operations for the foreseeable future. During the first six months of 2004, the Company had no revenues
and had operating losses of $1,520,904. The Companys accumulated deficit of $40,700,094 through June 30, 2004 has been funded primarily by the proceeds from the issuance of common stock (and interest earned on such proceeds), the licensing of
technology developed or acquired by the Company, limited product sales and royalties, and the sale of royalty rights. The Company will require substantial funding in order to complete research and development activities, manufacturing for clinical
trials, and the eventual marketing of any products that the Company intends to develop.



On June 11, 2003, the Company completed the sale of 3,184,713 shares of common stock pursuant to a private placement at a price of $.628 per share to Defiante Farmaceutica, L.d.a. (Defiante), a Portuguese company that is a
wholly owned subsidiary of Sigma-Tau, S.p.A., a pharmaceutical company headquartered in Rome, Italy. The Company received approximately $2 million in proceeds. In addition, the Company granted Defiante warrants to purchase up to $1.5 million of
additional restricted common stock of the Company at prices ranging from $1.00 to $1.25 per share (or higher under certain circumstances) over a period of 18 months.



On January 23, 2004, the Company completed the sale of 2,393,580 shares of common stock pursuant to a private placement at a price of $.95
per share to Defiante and several private investors. The Company received approximately $2.3 million in proceeds. In addition, the Company granted investors warrants to purchase 1 share of common stock for every 4 shares of common stock purchased in
the offering at a price of $1.50 per share over a period of 30 months.



Although the Company has no products that have received regulatory approval to date, the Companys Investigational New Drug Application was accepted by the United States Food and Drug Administration in December 2002 allowing the
Company to commence the human testing of Tb4 for dermal wounds. The Company initiated a Phase I human clinical trial in March 2003, which studies were
designed to establish safety in human subjects, and successfully completed the trial in September 2003. There were no significant adverse events associated with the drug in Phase I and results demonstrated it was well tolerated by all subjects. The
Company has recently raised additional capital for Phase II trials that are expected to begin in the third quarter of 2004. The Company believes the Phase II trials, which it hopes to conduct in a somewhat parallel fashion, will take approximately
12-15 months and will cost just over $2 million. The Company plans to independently develop Tb4 in the United States for chronic dermal wounds through
completion of Phase III clinical trials.



On January 22, 2004, the Company
exclusively licensed certain European rights to Tb4 to Defiante. Defiante will develop Tb4 for internal and external wounds in Europe and certain other contiguous and geographically relevant countries. The Agreement expires on a country-by-country basis upon the later of the
expiration of the last to expire of any granted patent in the territory having at least one valid claim covering the products then on the market, the expiration of any other exclusive or proprietary marketing rights or twelve years from the
effective date.



7



---

##### Table of Contents

Under the Agreement, Defiante will pay the Company a royalty on commercial sales and will purchase all required
Tb4 from the Company. When the Company completes positive Phase II clinical trials in the United States, Defiante must either pay the Company $5 million
or initiate pivotal Phase III clinical trials in Europe to maintain the license. Defiante also will be obligated to attain future clinical and regulatory milestones in the licensed territory. If those milestones are obtained, certain performance
criteria regarding commercial registration and minimum annual royalties will be required in each licensed country. Such obligations for potential milestones and the related performance criteria to be attained by Defiante are too attenuated at this
time to be estimable. The agreement does not prevent the Company from sublicensing the technology in countries outside the licensed territory, and has no impact on any U.S. rights.



At June 30, 2004, the Company had cash and cash equivalents totaling $1,612,875 and working capital of $1,536,954 and total assets were
$1,826,257. The Company believes that its cash balances will be sufficient to sustain current operations at least through December 31, 2004. The Company is currently pursuing several potential financing alternatives for continuation of its research,
development and clinical trials programs. There is no assurance that the Company will be able to raise additional capital necessary to timely execute its current plan of operation or continue such a plan of operation beyond December 2004 unless
substantial additional capital is raised.



As the Company utilizes a virtual
company strategy it does not currently expect to purchase or sell any properties or significant equipment and does not expect to have significant changes in the number of its employees. For more information about the Companys virtual company
strategy, see Item 1. Business of the Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.



Forward-looking Statements



When used in this Form 10-QSB and in future filings by the Company with the Securities and Exchange Commission, in the Companys press releases or other public or
shareholder communications, and in oral statements made with the approval of an authorized executive officer, the words or phrases will likely result, are expected to, will continue, is anticipated,
estimate, project or similar expressions are intended to identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain
risks and uncertainties, that could cause actual results to differ materially from historical results and those presently anticipated or projected. The Company wishes to caution readers not to place undue reliance on any forward-looking statements,
which speak only as of the date made. The Company wishes to advise readers that various factors could affect the Companys financial performance and could cause the Companys actual results for future periods to differ materially from any
opinions or statements expressed with respect to future periods in any current statements. These factors include, but are not limited to, the following: the Companys lack of revenues and history of losses; uncertainties related to the
Companys limited capital resources; risks associated with the development of the Companys products; uncertainties related to the regulatory process; the Companys lack of product diversification; the Companys dependence on
collaborative relationships with larger partners for the development, manufacturing and marketing of its products; reliance upon key personnel; the Companys ability to obtain and protect intellectual property rights; and competition. The
Company does not undertake, and specifically declines any obligation, to publicly release the result of any revisions that may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to
reflect the occurrence of anticipated or unanticipated events.



Item 3. Controls and Procedures



As of the end
of the period covered by this report, based on an evaluation of the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) the chief executive and financial officer
of the Company has concluded that the Companys disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in its Exchange Act reports is recorded, processed, summarized and reported
within the applicable time periods specified by the SECs rules and forms.



8



---

##### Table of Contents

There were no significant changes in the Companys internal controls or in any other factors that could
significantly affect those controls subsequent to the date of the most recent evaluation of the Companys internal controls by the Company, including any corrective actions with regard to any significant deficiencies or material weaknesses.



PART II  OTHER INFORMATION



Item 1. Legal Proceedings



None



Item 2. Changes in Securities



None



Item 3. Defaults Upon Senior Securities



None



Item 4. Submission of Matters to a Vote of Security Holders



None



Item 5. Other Information



None



9



---

##### Table of Contents

Item 6. Exhibits and Reports on Form 8-K



|(a) | Exhibits
|--- | --------



|            |  |                                                                                                                                |  |                                                                                                          
|----------- |  | ------------------------------------------------------------------------------------------------------------------------------ |  | ---------------------------------------------------------------------------------------------------------
|Exhibit No. |  | Description of Exhibit                                                                                                         |  | Reference*                                                                                               
|3.1         |  | Restated Certificate of Incorporation of the Company                                                                           |  | Exhibit 3.1 to Registration Statement No. 33-9370, Amendment No. 1 (filed November 26, 1986)             
|            |  |                                                                                                                               
|3.2         |  | Amendment to Restated Certificate of Incorporation of Company                                                                  |  | Exhibit 3.2 to the Companys Transitional Report on Form 10-K, File No. 0-15070 (filed March 18, 1991)   
|            |  |                                                                                                                               
|3.3         |  | Amendment to Restated Certificate of Incorporation of Company                                                                  |  | Exhibit 3.3 to the Companys Form 10-KSB, File No. 0-15070 (filed April 2, 2001)                         
|            |  |                                                                                                                               
|3.4         |  | Bylaws of Company                                                                                                              |  | Exhibit 3.2 to Registration Statement No. 33-9370 (filed October 8, 1986)                                
|            |  |                                                                                                                               
|3.5         |  | Amendment No. 1 to Bylaws of Company adopted August 11, 1989                                                                   |  | Exhibit 4.7 to Registration Statement No. 33-34551, Amendment No. 3 (filed June 21, 1990)                
|            |  |                                                                                                                               
|3.6         |  | Amendment No. 2 to Bylaws of Company adopted June 18, 1990                                                                     |  | Exhibit 4.8 to Registration Statement No. 33-34551, Amendment No. 3 (filed June 21, 1990)                
|            |  |                                                                                                                               
|3.7         |  | Amendment No. 3 to Bylaws of Company adopted November 30, 1990                                                                 |  | Exhibit 3.6 to the Companys Transitional Report on Form 10-K, File No. 0-15070 (filed March 18, 1991)   
|            |  |                                                                                                                               
|4.1         |  | Form of Stock Certificate                                                                                                      |  | Exhibit 4.1 to Registration Statement No. 33-9370, Amendment No. 1 (filed November 26, 1986)             
|            |  |                                                                                                                               
|4.2         |  | Rights Agreement, dated as of April 29, 1994, between the Company and American Stock Transfer & Trust Company, as Rights Agent |  | Exhibit 1 to the Companys Current Report on Form 8-K, File No. 0-15070 (filed May 2, 1994)              
|            |  |                                                                                                                               
|4.3         |  | Warrant Agreement, dated March 12, 1997                                                                                        |  | Exhibit 4.3 to the Companys Annual Report on Form 10-K, File No. 0-15070 (filed March 31, 1997)         
|            |  |                                                                                                                               
|4.4         |  | Warrant Agreement, dated January 23, 2004                                                                                      |  | Exhibit 4 to the Companys Registration Statement on Form SB-2, File No. 333-113417 (filed March 9, 2004)
|            |  |                                                                                                                               
|10.1        |  | Patent License Agreement  Exclusive, between the U.S. Public Health Service and the Company                                   |  | Exhibit 10.1 to the Companys Form 10-KSB, File No. 0-15070 (filed April 2, 2001)**                      
|            |  |                                                                                                                               
|10.2        |  | Amended and Restated Directors Stock Option Plan                                                                               |  | Exhibit 10.25 to the Companys Annual Report on Form 10-K, File No. 0-15070 (filed March 26, 1993)       
|            |  |                                                                                                                               
|10.3        |  | Amended and Restated 2000 Stock Option and Incentive Plan                                                                      |  | Filed as Exhibit A to the Companys definitive proxy materials, File No. 0-15070 (filed May 20, 2002)    



10



---

##### Table of Contents

|      |  |                                                                                        |  |                                                                                                                                        
|----- |  | -------------------------------------------------------------------------------------- |  | ---------------------------------------------------------------------------------------------------------------------------------------
|      |  |                                                                                       
|10.4  |  | Unit Purchase Agreement dated March 12, 1997                                           |  | Exhibit 10.25 to the Companys Annual Report on Form 10-K, File No. 0-15070 (filed March 31, 1997)                                     
|      |  |                                                                                       
|10.5  |  | Registration Rights Agreement, dated March 12, 1997                                    |  | Exhibit 10.26 to the Companys Annual Report of Form 10-K, File No. 0-15070 (filed March 31, 1997)                                     
|      |  |                                                                                       
|10.6  |  | Lease Agreement dated April 5, 2002 between the Company and HQ Global Workplaces, Inc. |  | Exhibit 10.7 to the Companys Annual Report on Form 10-KSB, File No. 0-15070 (filed March 31, 2003)                                    
|      |  |                                                                                       
|10.7  |  | Employment Agreement                                                                   |  | Exhibit 10.8 to the Companys Registration Statement on Form SB-2, File No. 333-113417 (filed March 9, 2004)                           
|      |  |                                                                                       
|10.8  |  | Employment Agreement                                                                   |  | Exhibit 10.9 to the Companys Registration Statement on Form SB-2, File No. 333-113417 (filed March 9, 2004)                           
|      |  |                                                                                       
|10.9  |  | License Agreement                                                                      |  | Exhibit 10.10 to the Companys Registration Statement on Form SB-2, Amendment No. 3, File No. 333-113417 (filed July 15, 2004) **      
|      |  |                                                                                       
|10.10 |  | Securities Purchase Agreement                                                          |  | Exhibit 10.11 to the Companys Registration Statement on Form SB-2, File No. 333-113417 (filed March 9, 2004)                          
|      |  |                                                                                       
|10.11 |  | Master Services Agreement                                                              |  | Exhibit 10.12 to the Companys Registration Statement on Form SB-2, Amendment No. 1, File No. 333-113417 (filed April 23, 2004)        
|      |  |                                                                                       
|31.1  |  | Certification dated August 16, 2004                                                    |  | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)                                               
|      |  |                                                                                       
|32.1  |  | Certification dated August 16, 2004                                                    |  | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith)

---

|* | Except where noted, the exhibits referred to in this column have heretofore been filed with the Securities and Exchange Commission as exhibits to the documents indicated and are
hereby incorporated by reference thereto. The Registration Statements referred to are Registration Statements of the Company.
|- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

|** | Portions of this document have been omitted pursuant to a request for confidential treatment
|-- | --------------------------------------------------------------------------------------------



|(b) | Reports on Form 8-K
|--- | -------------------



None.



11



---

##### Table of Contents

SIGNATURES



In accordance with the
requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.



|                      |  |                                      
|--------------------- |  | -------------------------------------
|                      |  | RegeneRx Biopharmaceuticals, Inc.    
|                      |  | (Registrant)                         
|                      | 
|Date: August 16, 2004 |  | /s/ J.J. Finkelstein                 
|                      |  | J.J. Finkelstein                     
|                      |  | President and Chief Executive Officer
|                      |  | (Principal Executive Officer and     
|                      |  | Principal Financial Officer)         



12